Federal Trade Commission.
Proposed Consent Agreement.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before October 17, 2008.
Interested parties are invited to submit written comments. Comments should refer to “Bioque Technologies, File No. 082 3095,” to facilitate the organization of comments. A comment filed in paper form should include this reference both in the text and on the envelope, and should be mailed or delivered to the following address: Federal Trade Commission/Office of the Secretary, Room 135-H, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. Comments containing confidential material must be filed in paper form, must be clearly labeled “Confidential,” and must comply with Commission Rule 4.9(c). 16 CFR 4.9(c) (2005). The FTC is requesting that any comment filed in paper form be sent by courier or overnight service, if possible, because U.S. postal mail in the Washington area and at the Commission is subject to delay due to heightened security precautions. Comments that do not contain any nonpublic information may instead be filed in electronic form by following the instructions on the web-Start Printed Page 57626based form at (http://secure.commentworks.com/ftc-BioqueTechnologies). To ensure that the Commission considers an electronic comment, you must file it on that web-based form.
FOR FURTHER INFORMATION CONTACT:
Richard Cleland, FTC Bureau of Consumer Protection, 600 Pennsylvania Avenue, NW, Washington, D.C. 20580, (202) 326-3088.End Further Info End Preamble Start Supplemental Information
Pursuant to section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and § 2.34 of the Commission Rules of Practice, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for September 18, 2008), on the World Wide Web, at http://www.ftc.gov/os/2008/09/index.htm. A paper copy can be obtained from the FTC Public Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW, Washington, D.C. 20580, either in person or by calling (202) 326-2222.
Public comments are invited, and may be filed with the Commission in either paper or electronic form. All comments should be filed as prescribed in the ADDRESSES section above, and must be received on or before the date specified in the DATES section.
Analysis of Agreement Containing Consent Order to Aid Public Comment
The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing a consent order from Bioque Technologies, Inc., Vittorio A. Bonomo, and Christine A. Guilman (together, “Respondents”).
The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement or make final the agreement’s proposed order.
This matter involves the advertising and promotion of Serum GV, a topical serum that, according to its label, contains, among other ingredients, extract of annona muricata, also known as graviola, derived from the soursop or guanabana tree. According to the FTC complaint, Respondents represented that Serum GV is an effective treatment for skin cancer, including melanoma, and that it prevents melanoma. The complaint alleges that Respondents failed to have substantiation for these claims. Also according to the FTC complaint, Respondents represented that Serum GV is recognized by the medical profession as an effective treatment for skin cancer and that it is clinically proven to prevent or treat melanoma. The complaint alleges that these claims are false and misleading because Serum GV is not recognized by the medical profession as an effective treatment for skin cancer and is not clinically proven to prevent or treat melanoma. The proposed consent order contains provisions designed to prevent Respondents from engaging in similar acts and practices in the future.
Part I of the proposed order requires Respondents to have competent and reliable scientific evidence substantiating any claims that a covered product or service is an effective treatment for skin cancer, including melanoma; prevents melanoma; is recognized by the medical profession as an effective treatment for skin cancer; or is clinically proven to prevent or treat melanoma. The provision further requires that such claims be true and non-misleading. A “covered product or service” is defined in the order as “any health-related service or program; or any food, dietary supplement, device, or drug, including, but not limited to, Serum GV.”
Part II of the proposed order requires the Proposed Respondents to possess competent and reliable scientific evidence for any claims about the absolute or comparative benefits, performance, efficacy, safety, or side effects of any covered product or service. The claims also must be truthful and non-misleading.
Part III of the proposed order prohibits Respondents from making future misrepresentations about the existence, contents, validity, results, conclusions, or interpretations of any test or study.
Part IV of the proposed order provides that the order does not prohibit Respondents from making representations for any drug that are permitted in labeling for the drug under any tentative final or final Food and Drug Administration (“FDA”) standard or under any new drug application approved by the FDA and representations for any product that are specifically permitted in labeling for that product by regulations issues by the FDA under the Nutrition Labeling and Education Act of 1990.
Part V of the proposed order requires Respondents to provide the FTC with a list of all consumers that they know purchased Serum GV and prohibits Respondents from using or disclosing the consumer information, except to a law enforcement agency or as required by law.
Part VI of the proposed order requires Respondents to send to the consumers identified in Part V a notification letter drafted by the FTC to inform them about the consent agreement.
Part VII of the proposed order provides for the payment of $9,035.85, the full amount of sales of the product, to the Commission.
Parts VIII through XII of the proposed order require Respondents to keep copies of relevant advertisements and materials substantiating claims made in the advertisements; to provide copies of the order to certain of their personnel; to notify the Commission of changes in corporate structure (for the corporate respondent) and changes in employment (for the individual respondents) that might affect compliance obligations under the order; and to file compliance reports with the Commission. Part XIII provides that the order will terminate after twenty (20) years under certain circumstances.
The purpose of this analysis is to facilitate public comment on the proposed order, and it is not intended to constitute an official interpretation of the agreement and proposed order or to modify in any way their terms. Start Printed Page 57627
By direction of the Commission.Start Signature
Donald S. Clark
1. The comment must be accompanied by an explicit request for confidential treatment, including the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. The request will be granted or denied by the Commission’s General Counsel, consistent with applicable law and the public interest. See Commission Rule 4.9(c), 16 CFR 4.9(c).Back to Citation
[FR Doc. E8-23328 Filed 10-2-08; 8:45 am]
BILLING CODE 6750-01-S